The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0087-2022·Announced 2021-11-10

Irbesartan Tablets Recalled for Impurity in Active Ingredient

Lupin Pharmaceuticals is recalling Irbesartan tablets due to the detection of N-nitrosoirbesartan impurity in the active pharmaceutical ingredient. The recall affects 30-count and 90-count bottles distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class II recall, which typically warrants a severity score of at least 3. Given that the hazard involves a potentially toxic impurity (N-nitrosoirbesartan, a nitrosamine) in a prescription medication with nationwide distribution, this meets the threshold for Severe (score 4) per the rubric criterion for FDA Class II recalls with significant risk factors.

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling Irbesartan Tablets USP, 150 mg, distributed as 30-count (NDC 68180-411-06) and 90-count (NDC 68180-411-09) bottles. The recall involves 134,016 bottles and affects multiple lot numbers with expiration dates ranging from August 2021 through April 2022.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations in the manufacturing process. The issue identified is the presence of N-nitrosoirbesartan, an impurity detected in the active pharmaceutical ingredient (API).

The affected product was distributed to major distributors who may have further distributed the product nationwide. Patients taking the recalled lots should consult their healthcare provider or pharmacist about whether they may have received affected tablets and what steps to take regarding their medication.

The FDA classified this recall as Class II. Consumers with questions about the recall should contact their pharmacy or healthcare provider.

The recalled product

Product
IRBESARTAN (IRBESARTAN)
Brand
IRBESARTAN
Manufacturer
Lupin Pharmaceuticals Inc.
Category
Drug — Prescription / Cardiovascular
Hazard
Affected units
134,016

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

  • a) Lot# H804403
  • exp. date 31/08/2021 H805251
  • exp. date 30/11/2021 H805640
  • exp. date 30/11/2021 H901580
  • exp. date 30/04/2022 b) Lot# H804492
  • exp. date 31/08/2021 H805252
  • exp. date 30/11/2021 H805253
  • exp. date30/11/2021 H805641
  • exp. date30/11/2021 H805642
  • exp. date30/11/2021 H805643
  • exp. date 30/11/2021 H901581
  • exp. date 30/04/2021 H902139
  • exp. date 30/04/2022 H902140
  • exp. date 30/04/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Lupin Pharmaceuticals Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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Same manufacturer · Lupin Pharmaceuticals Inc.

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Same hazard · nitrosamine impurity

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